Eliquis 2.5 mg (Rivaroxaban)

Adult dose

This medicine may be taken with or without food. 1. Adults 1) Reduction in the incidence of atherothrombotic events (death due to cardiovascular causes, myocardial infarction) in patients who have experienced acute coronary syndrome with elevated cardiac biomarkers, when administered in combination with aspirin or with aspirin and clopidogrel The recommended dose of this medicine is 2.5 mg twice daily. Patients should take aspirin 75-100 mg once daily, or aspirin 75-100 mg once daily and clopidogrel 75 mg, together with this medicine. Treatment for at least 24 months is recommended. Since patients who have experienced acute coronary syndrome remain at risk of cardiovascular events, extending the duration of treatment may be beneficial. Treatment with this medicine at 2.5 mg should be initiated as soon as possible after the acute coronary syndrome event has stabilized (including revascularization). Treatment may be started as early as 24 hours after hospitalization, once parenteral anticoagulant therapy has been appropriately discontinued. 2) Coronary artery disease (CAD) or peripheral artery disease (PAD) The recommended dose of this medicine is 2.5 mg twice daily, and aspirin 75-100 mg once daily should be taken together with this medicine. The duration of treatment with this medicine should be determined by regularly assessing each patient's condition and considering the risk of bleeding in relation to the risk of thrombotic events. During treatment with this medicine, for patients who experience an acute thrombotic event or undergo a vascular procedure, and for patients who require dual antiplatelet therapy, the decision whether to continue this medicine at 2.5 mg twice daily should be assessed according to the antiplatelet regimen and the type of thrombotic event or vascular procedure. The efficacy and safety of concomitant use of this medicine with aspirin and clopidogrel have been studied only in patients with acute coronary syndrome. Concomitant use of this medicine with dual antiplatelet therapy has not been studied in patients with coronary artery disease or peripheral artery disease. 3) If you forget to take this medicine If you forget to take this medicine, continue with the recommended dose of 2.5 mg at the next scheduled dosing time. Do not take twice the recommended daily dose to make up for a missed dose. 2. Switching medications 1) Switching from a vitamin K antagonist to this medicine The INR value will be falsely elevated after taking this medicine, regardless of the dose. INR is not suitable for measuring the anticoagulant activity of this medicine and should not be used for this purpose. 2) Switching from this medicine to a vitamin K antagonist Inadequate anticoagulation may occur while switching from this medicine to a vitamin K antagonist. Adequate anticoagulation should be maintained continuously while switching to another anticoagulant. Note that this medicine may affect INR elevation. Patients switching from this medicine to a vitamin K antagonist should take the vitamin K antagonist concomitantly until INR≥2.0. For the first 2 days after switching, administer the standard dose of the vitamin K antagonist, and thereafter administer the dose of the vitamin K antagonist according to INR testing. However, in patients receiving this medicine and a vitamin K antagonist concomitantly, INR should not be tested until 24 hours after taking this medicine. Once this medicine is discontinued, INR may be tested 24 hours after the last dose. 3) Switching from a parenteral anticoagulant to this medicine For patients receiving a parenteral anticoagulant, start this medicine 0~2 hours before the next scheduled dose of the parenteral agent (e.g., low-molecular-weight heparin), or when a continuously administered parenteral agent (e.g., intravenous unfractionated heparin) is discontinued. 4) Switching from this medicine to a parenteral anticoagulant Discontinue this medicine and start the parenteral anticoagulant at the time the next dose of this medicine would have been due. 3. Patients with renal impairment No dose adjustment is necessary in patients with mild renal impairment with creatinine clearance 50-80 mL/min. Use of this medicine is not recommended in patients with severe renal impairment with creatinine clearance less than 15 mL/min, as there is no clinical experience in these patients. 1) Reduction in the incidence of atherothrombotic events (death due to cardiovascular causes, myocardial infarction) in patients who have experienced acute coronary syndrome with elevated cardiac biomarkers, when administered in combination with aspirin or with aspirin and clopidogrel No dose adjustment is necessary in patients with moderate renal impairment (creatinine clearance 30-49 mL/min). Limited clinical experience in patients with severe renal impairment (creatinine clearance 15-29 mL/min) indicates that blood concentrations of this medicine increased significantly; therefore, administer this medicine with caution. 4. Patients with hepatic impairment Avoid administering this medicine to patients with liver disease associated with coagulopathy and to patients with moderate (Child-Pugh B) or severe (Child-Pugh C) hepatic impairment. Increased exposure to this medicine and an increased risk of bleeding may occur in these patients. 5. For patients who cannot swallow tablets, immediately before use, this medicine may be crushed and mixed with a drink such as water or applesauce for oral administration. This medicine may also be crushed and administered with a small amount of water through a gastrointestinal tube. Before administering this medicine through a gastrointestinal tube, confirm that the tube is correctly positioned, and flush the tube with water after administration.

This medication is an anticoagulant that thins the blood to prevent clot formation. During treatment, it is crucial to carefully monitor for signs of bleeding, as the risk of bleeding may be increased. If serious bleeding occurs, immediately discontinue use and follow a doctor's instructions. This drug should not be administered to certain patients, such as those allergic to this medication or its components, those with existing serious bleeding, those with severely impaired liver function, and those who are pregnant or breastfeeding. Furthermore, it should be used with caution or not at all in patients with multiple conditions that heighten the bleeding risk or those taking other anticoagulants. In patients with decreased kidney function, the concentration of this drug in the blood may increase, elevating the risk of bleeding; thus, the decision to administer it should be made under a physician's judgment. This drug can lead to various side effects, including bleeding as well as anemia, skin rashes, and liver function abnormalities, so consult healthcare professionals immediately if any abnormal symptoms arise. In particular, serious adverse reactions such as severe bleeding, allergic reactions, and agranulocytosis can occur, necessitating caution. This medication may interact with specific drugs, and it may increase the bleeding risk when taken with azole antifungals, some antibiotics, other anticoagulants, and non-steroidal anti-inflammatory drugs. Therefore, inform healthcare professionals about any other medications being taken. Women who are pregnant or breastfeeding should not take this medication, and women of childbearing potential should ensure adequate contraception during treatment. Elderly patients or those with impaired kidney function have an increased risk of bleeding and should take extra precautions. If surgery or invasive procedures are planned while taking this medication, it should be stopped at least 12 to 24 hours prior, and it should not be resumed until the risk of bleeding has passed. Drowsiness or fainting may occur, which could affect driving or operating machinery; avoid these activities if such symptoms arise. In case of overdose, the risk of bleeding is significantly heightened, and immediate medical attention is required.

Bleeding, anemia, thrombocytosis, tachycardia, ocular hemorrhage, gingival bleeding, gastrointestinal bleeding, stomach pain, abdominal pain, dyspepsia, nausea, constipation, diarrhea, vomiting, dry mouth, fever, peripheral edema, systemic weakness and energy decrease, discomfort, localized edema, liver dysfunction, jaundice, allergic reactions, allergic dermatitis, post-treatment bleeding, bruising, wound exudate, pseudoaneurysm, increased transaminases, elevated bilirubin, increased alkaline phosphatase, increased LDH, increased lipase, increased amylase, increased transaminases, elevated bilirubin conjugates, limb pain, hemorrhagic arthropathy, muscle bleeding, dizziness, headache, cerebral and intracranial hemorrhage, syncope, urogenital bleeding, renal impairment, non-bleeding, hemoptysis, itching, rash, petechial bleeding, skin and subcutaneous bleeding, urticaria, hypotension, hematoma, angioedema, allergic edema, anaphylactic shock, cholestasis, hepatitis, thrombocytopenia, agranulocytosis, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reactions with eosinophilia and systemic symptoms, eosinophilic pneumonia, anticoagulant-related renal pathology, severe uterine bleeding, postoperative hematoma, hemorrhagic duodenal ulcer, bloody stools, melena, myocardial infarction, arthralgia, facial flushing, deep vein thrombosis, joint dislocation, Pseudomonas aeruginosa wound infection, nasopharyngitis, cardiomyopathy, increased cardiac enzymes, congestive heart failure, urinary tract infection, membranous colitis, asthma, pulmonary edema, pleural effusion, oral mucosal ulcer, high fever, severe dysphagia, angina, postoperative hematoma

This medication should be stored in a tightly sealed container to prevent exposure to air or moisture. It is important to keep the storage temperature between 1 and 30 degrees Celsius at room temperature.

Appearance

Bright yellow, round, film-coated tablets

Package unit

30 tablets (10 tablets/PTP packaging x 3)